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Atypical Antipsychotic
Clozapine for Schizophrenia (REVISIT-C Trial)
Phase 4
Recruiting
Led By Ragy Girgis, MD
Research Sponsored by New York State Psychiatric Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 days
Treatment Varies
Follow Up 14 days
Awards & highlights
REVISIT-C Trial Summary
This trial will study whether clozapine, a medication used to treat schizophrenia, is effective in reducing the risk of violent acts in people with schizophrenia who have a recent history of violence.
Who is the study for?
This trial is for adults with schizophrenia or schizoaffective disorder who have been violent recently. They must be medically stable, able to consent, and not on certain long-term medications. Pregnant women, those intolerant to clozapine, with serious medical conditions or high suicide risk are excluded.Check my eligibility
What is being tested?
The study compares the effectiveness of clozapine versus usual antipsychotic treatments in reducing violence among individuals with schizophrenia over a 24-week period across seven sites. Participants will be randomly assigned to one of the two treatment groups.See study design
What are the potential side effects?
Clozapine can cause side effects like drowsiness, increased saliva production, constipation, and more severe issues such as low white blood cell count (which can increase infection risk), heart inflammation or bowel obstruction in those allergic.
REVISIT-C Trial Timeline
Screening ~ 3 days6 visits
Treatment ~ Varies
Follow Up ~ 14 days1 visit
Screening ~ 3 days
Treatment ~ Varies
Follow Up ~14 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Effectiveness outcome: Violent acts
Syndrome
Secondary outcome measures
Effect on aggression
Alcohol or Other Drugs use
Other outcome measures
Interventions to Prevent Violence
Side effects data
From 2008 Phase 4 trial • 25 Patients • NCT0000165631%
Increased appetite
31%
Hypersalivation
17%
tachycardia >100 beats/min (supine)
15%
Somnolence
15%
Constipation
9%
Hypertension
8%
Difficulty concentrating
8%
Abnormal white blood count
8%
Insomnia
8%
Enuresis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Olanzapine Group
Clozapine Group
REVISIT-C Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ClozapineExperimental Treatment1 Intervention
treatment with clozapine naturalistically administered (as per clinical guideline).
Group II: Treatment as usualActive Control1 Intervention
open label naturalistic treatment as usual with any antipsychotic other than clozapine
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Clozapine
FDA approved
Find a Location
Who is running the clinical trial?
New York State Psychiatric InstituteLead Sponsor
475 Previous Clinical Trials
153,375 Total Patients Enrolled
30 Trials studying Schizophrenia
85,234 Patients Enrolled for Schizophrenia
National Institute of Mental Health (NIMH)NIH
2,798 Previous Clinical Trials
2,660,638 Total Patients Enrolled
250 Trials studying Schizophrenia
89,181 Patients Enrolled for Schizophrenia
Ragy Girgis, MDPrincipal InvestigatorNew York State Psychiatric Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have a serious condition affecting my blood or nervous system.I tried clozapine without success or had side effects.If you have had recent thoughts or behaviors related to suicide, or if your doctor thinks you are at a high risk for suicide, you may not be able to participate in this study.You have committed a violent act in the past six months, as determined by the MCVI assessment.I have a history of intellectual impairment.I am eligible for treatment with clozapine or standard therapy and not currently on long-term injectables.
Research Study Groups:
This trial has the following groups:- Group 1: Clozapine
- Group 2: Treatment as usual
Awards:
This trial has 5 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 170 null
- Follow Ups: You may be asked to continue sharing information regarding the trial for 14 Months after you stop receiving the treatment.
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